Senior Regulatory Affairs Director

Job Description

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Oncology Regulatory Science and Strategy

Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) developing and implementing the global strategy on complex oncology programs with multiple indications. In addition, the SRAD has the ability to function in dual capacity by serving as the regional lead based on location. The SRAD establishes external relationships with key stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the Regulatory community.

What you’ll do

• Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team.
• Ensure that the strategy is crafted to deliver approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
• Lead the assessment of emerging data against aspirations and update Leadership on project risks/mitigation activities.
• Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic advice and accountable for all regulatory activities.
• Own the delivery of all milestones on your team including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations.
• Demonstrate strategic leadership skills thereby contributing to effective product development.
• Promote novel regulatory initiatives internally and engage externally on the corresponding topics. Lead the development of novel tools and technology.
• Partner and influence developing views/guidance on a global scale.

Education, Qualifications, Skills and Experience

Essential for the role:

• An advanced degree in a science related field and/or other appropriate knowledge/experience.
• Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired.
• Previous experience in leading major health authority interactions.
• Solid knowledge of regulatory affairs within several therapeutic areas in early and late development.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
• Proven leadership experience.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.

Desirable for the role:

• Previous experience with FDA advisory committee and EMA oral explanation hearings would be a plus
• Previous experience working on due diligence activities and in a business alliance environment.
• Ability to work strategically within a complex, business critical and high-profile development program.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.

Where can I find out more?

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.